HIV InfectionsNCT06927856
The Test-to-PrEP Study
A study testing Test-to-PrEP and Access by Referral in people with HIV Infections, run by University of Miami at 1 site in United States.
Trial summary
To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Test-to-PrEP and Access by Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stated willingness to provide informed consent.
- Stated willingness to comply with all study procedures.
- Stated availability for the duration of the study.
- Ability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
- Currently prescribed PrEP by RAPID clinics, including those initiating PrEP on the same day as study enrollment.
- Provision of electronic informed consent prior to completion of the Quick Response (QR)-linked survey instruments.
Who cannot join
- Inability or refusal to provide informed consent (e.g., cognitive impairment).
- Unable or unwilling to comply with study procedures per study investigator
- Inability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
- Aged 17 years or younger.
- Failure to provide electronic informed consent prior to starting QR-linked Alter survey tools.
- Age 17 years or younger.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Claudia Santos, MBA, 305-243-9034, csantos15@miami.edu
Stefani Butts, MPH, 305243997 ext. Dobleck-Lewis, sab321@med.miami.edu
About this study
Official title: Test-to-PrEP: A Randomized Hybrid Implementation/Effectiveness Trial of a Social Network Strategy to Increase Equitable Reach of HIV Testing and PrEP Information
To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.
- Conditions
- HIV Infections
- Being tested
- Test-to-PrEP, Access by Referral
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-to-PrEPBehavioural
Participants, called Egos, will come once to the clinic throughout the duration of the study, for up to 1 hour. During the visit, participants will receive up to 4 Test-to-PrEP Packs, which include an HIV self-test kit and HIV prevention education materials and a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Test-to-PrEP Packs to Social Network Contacts (peers), called Alters.
Access by ReferralBehavioural
Participants, called Egos, will receive up to 4 Access by Referral Cards once. Participants will receive a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Access by Referral Cards to Social Network Contacts (peers), also called Alters. The Referral Card can be used to order a Test-to-PrEP Pack, including the HIV self-test and HIV prevention education material, that will be mailed to an address of the Alter's choice.
| Study group | Role | What they receive |
|---|---|---|
| Test-to-PrEP group | Experimental | Participants in this group will receive the Test-to-PrEP intervention for up to 1 year Receives: Behavioral: Test-to-PrEP |
| Access by Referral group | Experimental | Participants in this group will receive the Access by Referral intervention for up to 1 year Receives: Behavioral: Access by Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Alter participants per ego who use the HIV self-test kit
Number of Alter participants per ego who use an HIV self-test kit, indicated by completion of the Post-Test Survey.
Measured: Up to 6 months
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
Measured: Up to 6 months
Secondary outcomes (2)
Number of Alters per ego initiating PrEP
Number of Alters per ego initiating PrEP
Measured: Up to 6 months
Alters' self-reported PrEP knowledge as indicated by the Post-Test Survey.
Scores on Post-Test Survey range from 0-100. Higher scores indicate higher PrEP knowledge.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Susanne Doblecki-Lewis, University of Miami
- Investigators
- Susanne Dobleck-Lewis, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927856
- Sponsor's protocol ID
- 20240478
- Other IDs
- R01MH138190-01
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-to-PrEP: A Randomized Hybrid Implementation/Effectiveness Trial of a Social Network Strategy to Increase Equitable Reach of HIV Testing and PrEP Information
- ClinicalTrials.gov ID
- NCT06927856
- Acronym / sponsor ID
- 20240478
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test-to-PrEP group | Experimental | Behavioral: Test-to-PrEPParticipants in this group will receive the Test-to-PrEP intervention for up to 1 year |
| Access by Referral group | Experimental | Behavioral: Access by ReferralParticipants in this group will receive the Access by Referral intervention for up to 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stated willingness to provide informed consent.
- Stated willingness to comply with all study procedures.
- Stated availability for the duration of the study.
- Ability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
- Currently prescribed PrEP by RAPID clinics, including those initiating PrEP on the same day as study enrollment.
Key exclusion criteria (6 listed)
- Inability or refusal to provide informed consent (e.g., cognitive impairment).
- Unable or unwilling to comply with study procedures per study investigator
- Inability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
- Aged 17 years or younger.
- Failure to provide electronic informed consent prior to starting QR-linked Alter survey tools.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test-to-PrEPParticipants, called Egos, will come once to the clinic throughout the duration of the study, for up to 1 hour. During the visit, participants will receive up to 4 Test-to-PrEP Packs, which include an HIV self-test kit and HIV prevention education materials and a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Test-to-PrEP Packs to Social Network Contacts (peers), called Alters. | Behavioural | Test-to-PrEP group |
| Access by ReferralParticipants, called Egos, will receive up to 4 Access by Referral Cards once. Participants will receive a brief (approximately 15 minutes) training. The training includes instructions on how to initiate conversations related to HIV, HIV testing, and HIV prevention, as well as proper handling of the HIV self-test kit. Participants are asked to distribute the Access by Referral Cards to Social Network Contacts (peers), also called Alters. The Referral Card can be used to order a Test-to-PrEP Pack, including the HIV self-test and HIV prevention education material, that will be mailed to an address of the Alter's choice. | Behavioural | Access by Referral group |
Primary outcome
Number of Alter participants per ego who use the HIV self-test kit
Time frame: Up to 6 months
Number of Alter participants per ego who use an HIV self-test kit, indicated by completion of the Post-Test Survey.
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
Time frame: Up to 6 months
Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
2 secondary outcomes
Number of Alters per ego initiating PrEP
Time frame: Up to 6 months
Alters' self-reported PrEP knowledge as indicated by the Post-Test Survey.
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Dobleck-Lewis, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test-to-PrEP and Access by Referral in people with HIV Infections, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Doblecki-Lewis, MD (3052434037, SDoblecki@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Alter participants per ego who use the HIV self-test kit (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.